Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction - Full Text View

Sponsor:	Javelin Pharmaceuticals
Information provided by:	Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00390312

Purpose

This study involves approximately 200 patients designed to evaluate the efficacy and safety of intranasal (IN) morphine 7.5 mg and 15 mg, intravenous morphine (IV) 7.5 mg, immediate release oral (PO) morphine 60 mg or placebo in patients with acute postsurgical pain following third molar extraction.

Condition	Intervention	Phase
Post-Operative Pain Third Molar Extraction	Drug: Intranasal Placebo Drug: Intranasal Morphine 15 mg Drug: Immediate Release Oral Morphine 60 mg Drug: Intravenous morphine Drug: Intranasal morphine 7.5 mg Drug: Oral placebo Drug: Intravenous placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Single Dose Comparison of Analgesic Efficacy and Safety of Intranasal Morphine, Immediate Release Oral Morphine, Intravenous Morphine and Placebo in Postsurgical Dental Pain

Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome Measures:

Total pain relief (TOTPAR) at the 0-2 hour time interval calculated as the time-weighted sum of the Pain Relief (PR) scores for the time interval 0-2 hours [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Other measures of pain relief [ Time Frame: Several time points ] [ Designated as safety issue: Yes ]

Enrollment:	225
Study Start Date:	September 2001
Study Completion Date:	November 2001
Primary Completion Date:	November 2001 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 4 Intravenous morphine	Drug: Intravenous morphine Intravenous morphine 7.5 mg
Experimental: 1 Intranasal morphine 7.5 mg	Drug: Intranasal morphine 7.5 mg Intranasal morphine 7.5 mg
Experimental: 2 Intranasal morphine 15 mg	Drug: Intranasal Morphine 15 mg Intranasal Morphine 15 mg
Active Comparator: 3 Oral morphine 60 mg	Drug: Immediate Release Oral Morphine 60 mg Immediate Release Oral Morphine 60 mg
Placebo Comparator: 5 Intranasal placebo	Drug: Intranasal Placebo Intranasal placebo
Placebo Comparator: 6 Oral placebo	Drug: Oral placebo Oral placebo
Placebo Comparator: 7 Intravenous placebo	Drug: Intravenous placebo Intravenous placebo

Detailed Description:

Diagnosis and Main Criteria for Inclusion: Dental outpatients undergoing the removal of 3 or more third molars (2 of which were required to be mandibular and both must be bony impacted third molars).

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female 18-40 years of age
Surgical extraction of at least three or more third molars (two must be mandibular and both must be bony impacted third molars)
Moderate or severe pain within 6 hours of completion of surgery

Exclusion Criteria:

Other oral surgical procedures during the same session except the removal of supernumerary third molars
Evidence of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety
Chronic respiratory insufficiency such that treatment with an opioid analgesic is contraindicated
Allergy to shellfish

Additional Inclusion/Exclusion Criteria May Apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390312

Sponsors and Collaborators

Javelin Pharmaceuticals

Investigators

Principal Investigator:

Kyle Christensen, DDS

Jean Brown Associates, Inc.

More Information

No publications provided

Responsible Party:	Amy Cohen/Director, Clinical Operations, Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00390312 History of Changes
Other Study ID Numbers:	MOR-001
Study First Received:	October 17, 2006
Last Updated:	December 28, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Javelin Pharmaceuticals:

Post operative pain
Third molar extraction
Dental surgery
Morphine

Additional relevant MeSH terms:

Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Morphine
Analgesics, Opioid
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012